Online Surveillance of Treatment of Children With Growth Hormone Deficiency With ZOMACTON
Non-interventional Study With ZOMACTON in Children With Growth Hormone Deficiency
1 other identifier
observational
1,034
1 country
59
Brief Summary
The purpose of this study is to investigate long-term treatment with Zomacton® for pituitary short stature in children with insufficient growth hormone production and/or short stature caused by Turner syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2007
Longer than P75 for all trials
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 1, 2011
CompletedFirst Posted
Study publicly available on registry
June 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJune 2, 2017
June 1, 2017
8.5 years
June 1, 2011
June 1, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy of ZOMACTON
measured by: body height, increase of body height per annum
Up to 5 years
Secondary Outcomes (2)
Efficacy measured by further parameters
Up to 5 years
Safety of Zomacton and application device
Up to 5 years
Study Arms (1)
Growth hormone
Children with growth hormone deficiency
Interventions
Eligibility Criteria
Clinics and private practices
You may qualify if:
- therapeutic need according to SPC
- written informed consent
You may not qualify if:
- contraindications according to SPC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ferring Pharmaceuticalslead
- Ferring Arzneimittel GmbHcollaborator
Study Sites (59)
Investigational Site
Konrad-Adenauer-Allee 33, Augsburg, Germany
Investigational Site
Friedrichstr. 36-42, Dresden, Germany
Investigational Site
Blücherstr. 4, Erfurt, Germany
Investigational Site
Loschgestr. 15, Erlangen, Germany
Investigational Site
Düsseldorfer Str. 1-7, Frankfurt (Main), Germany
Investigational Site
Stresemannallee 1-3, Frankfurt (Main), Germany
Investigational Site
Wilhelm-Breckow-Allee 20, Gummersbach, Germany
Investigational Site
Seminarstr. 2, Heidelberg, Germany
Investigational Site
Koblenzer Str. 115-155, Koblenz, Germany
Investigational Site
Elisenstr. 12, Oldenburg, Germany
Investigational Site
Elisabethenstr. 15, Ravensburg, Germany
Investigational Site
Chausseestr. 119, State of Berlin, Germany
Investigational Site
Marienstr. 6-8, Vechta, Germany
Investigational Site, Geranienweg 7
Bad Langensalza, Germany
Investigational Site, Augustenburger Platz 1
Berlin, Germany
Investigational Site, Chausseestraße 119
Berlin, Germany
Investigational Site. Gotlindestraße 2 - 20
Berlin, Germany
Investigational Site, Burgsteig 13
Bielefeld, Germany
Investigational Site, Alexandrinenstraße 5
Bochum, Germany
Investigational Site, Alter Markt 4
Bochum, Germany
Investigational Site, Flemmingstraße 4
Chemnitz, Germany
Investigational Site, Kerpener Str. 62 (Haus 26)
Cologne, Germany
Investigational Site, Dr.-Friedrich-Steiner-Straße 5
Datteln, Germany
Investigational Site, Fetscherstraße 74
Dresden, Germany
Investigational Site, Hospitalstraße 44
Düren, Germany
Investigational Site, Düsseldorfer Straße 8
Düsseldorf, Germany
Investigational Site, Hufelandstraße 55
Essen, Germany
Investigational Site, Lyoner Straße 54
Frankfurt am Main, Germany
Investigational Site, Mathildenstraße 1
Freiburg im Breisgau, Germany
Investigational Site, Pippinplatz 4
Gauting, Germany
Investigational Site, Am Markt 3
Gehrden, Germany
Investigational Site, Robert-Koch-Straße 40
Göttingen, Germany
Investigational Site, Ernst-Grube-Straße 40
Halle, Germany
Investigational Site, Bleickenallee 38-40
Hamburg, Germany
Investigational Site, Lornsenstraße 4-6
Hamburg, Germany
Investigational Site, Werlerstraße 130
Hamm, Germany
Investigational Site, Brabeckstraße 153
Hanover, Germany
Investigational Site, Im Neuenheimer Feld 430
Heidelberg, Germany
Investigational Site, Seminarstraße 2
Heidelberg, Germany
Investigational Site, Kirrberger Straße
Homburg, Germany
Investigational Site, Kochstraße 2
Jena, Germany
Investigational Site, Ettlinger Straße 27
Karlsruhe, Germany
Investigational Site, Schwanenweg 20
Kiel, Germany
Investigational Site, Koblenzer Str. 115-155
Koblenz, Germany
Investigational Site, Lutherplatz 40
Krefeld, Germany
Investigational Site, Johannisplatz 1
Leipzig, Germany
Investigational Site, Liebigstraße 20 a
Leipzig, Germany
Investigational Site, Birkenallee 34
Magdeburg, Germany
Investigational Site, Leipziger Straße 44
Magdeburg, Germany
Investigational Site, Kölner Platz 1
München, Germany
Investigational Site, Lindwurmstraße 4
München, Germany
Investigational Site, Promenadeplatz 12
München, Germany
Investigational Site, Albert-Schweitzer-Straße 33
Münster, Germany
Investigational Site, Helmut-Just-Straße 6
Neubrandenburg, Germany
Investigational Site, St.-Johannis-Mühlgasse 19
Nuremberg, Germany
Investigational Site, Dr.-Eden-Straße 10
Oldenburg, Germany
Investigational Site, Hauptkanal rechts 75
Papenburg, Germany
Investigational Site, Pettenkoferstraße 10
Rosenheim, Germany
Investigational Site, Eythstraße 24
Ulm, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2011
First Posted
June 3, 2011
Study Start
December 1, 2007
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
June 2, 2017
Record last verified: 2017-06